ACT ARTIC E1 HIP BRG 28X46MM
Report
- Report Number
- 0001825034-2019-01828
- Event Type
- Injury
- Date Received
- April 23, 2019
- Date of Event
- March 29, 2019
- Report Date
- July 25, 2019
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K101336
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 0100102618 WAGNER SL REVISION® HIP STEM, UNCEMENTED, ø 18/265, TAPER 12/14 LOT# 2934288. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND XRAYS WHICH INDICATED MULTIPLE DISLOCATIONS. VISUAL INSPECTION OF THE BEARING IDENTIFIED LIGHT SCRATCHES ON THE LIP OF THE OPEN END ALL ALONG THE BACKSIDE. THERE WERE ALSO GOUGES OR INDENTATIONS THAT CAN BE FELT WITH THE FINGERNAIL ON THE OUTER DIAMETER. DIMENSIONAL ANALYSIS CANNOT BE PERFORMED DUE TO THE NATURE OF DAMAGES DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT THA ON AN UNKNOWN DATE, AT AN UNKNOWN HOSPITAL, BY UNKNOWN SURGEON. THE PATIENT ACQUIRED AN INFECTION AND IN THE OTHER HOSPITAL, THEY REMOVED UNKNOWN PRODUCT IN A GIRDLESTONE PROCEDURE. SUBSEQUENTLY, PATIENT HAD REVISION OF THE LEFT THA TO ZIMMER BIOMET PRODUCT AND WAS REVISED APPROXIMATELY 8 DAYS LATER DUE TO TURNING IN BED AND DISLOCATING HIP. THE PATIENT WAS REDUCED WITHOUT REVISION. PATIENT DISLOCATED AGAIN APPROXIMATELY 45 DAYS LATER DURING X-RAYS AND WAS REDUCED AGAIN WITHOUT REVISION. SUBSEQUENTLY, THE PATIENT WAS REVISED 8 DAYS AFTER 2ND DISLOCATION AS SHE DISLOCATED AGAIN. THE LINER, HEAD, AND STEM WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NONE WAS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 110024465, G7 DUAL MOBILITY LINER 46MM G, LOT# 143090; ITEM# 010000666, G7 PPS LTD ACET SHELL 58G, LOT# 6320695; ITEM# 00801802802 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER, LOT# 64003482; ITEM# UNKNOWN, UNKNOWN STEM, LOT# UNKNOWN. FOREIGN SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 -01826.
IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT THA ON AN UNKNOWN DATE, AT AN UNKNOWN HOSPITAL, BY UNKNOWN SURGEON. THE PATIENT ACQUIRED AN INFECTION AND IN THE OTHER HOSPITAL, THEY REMOVED UNKNOWN PRODUCT IN A GIRDLESTONE PROCEDURE. SUBSEQUENTLY, PATIENT HAD REVISION OF THE LEFT THA TO ZIMMER BIOMET PRODUCT AND WAS REVISED APPROXIMATELY 8 DAYS LATER DUE TO TURNING IN BED AND DISLOCATING HIP. THE PATIENT WAS REDUCED WITHOUT REVISION. PATIENT DISLOCATED AGAIN APPROXIMATELY 45 DAYS LATER DURING X-RAYS AND WAS REDUCED AGAIN WITHOUT REVISION. SUBSEQUENTLY, THE PATIENT WAS REVISED 8 DAYS AFTER 2ND DISLOCATION AS SHE DISLOCATED AGAIN. THE LINER, HEAD, AND STEM WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NONE WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333063 | ACT ARTIC E1 HIP BRG 28X46MM | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 490510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |